Round Drain type Jackson-Pratt Fr 7 w/trocar 24201

GUDID 18034139294633

The surgical drainage is a sterile and single-use device. The drainage has depth markings, graduated from the end of the perforated section: these markings facilitate accurate positioning of the drainage in the wound. The drainage is biocompatible and hemocompatible (in accordance with the regulations in force). The product is compatible for use with gravity or suction drainage systems.

REDAX SPA

Closed-wound drain
Primary Device ID18034139294633
NIH Device Record Keyfc038435-ccf7-4158-b7ed-e78171c0ca68
Commercial Distribution StatusIn Commercial Distribution
Brand NameRound Drain type Jackson-Pratt Fr 7 w/trocar
Version Model Number24201
Catalog Number24201
Company DUNS338664915
Company NameREDAX SPA
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+17868187337
Emailchristian.costantini@redax.it
Phone+17868187337
Emailchristian.costantini@redax.it
Phone+17868187337
Emailchristian.costantini@redax.it
Phone+17868187337
Emailchristian.costantini@redax.it
Phone+17868187337
Emailchristian.costantini@redax.it
Phone+17868187337
Emailchristian.costantini@redax.it
Phone+17868187337
Emailchristian.costantini@redax.it
Phone+17868187337
Emailchristian.costantini@redax.it
Phone+17868187337
Emailchristian.costantini@redax.it
Phone+17868187337
Emailchristian.costantini@redax.it
Phone+17868187337
Emailchristian.costantini@redax.it
Phone+17868187337
Emailchristian.costantini@redax.it
Phone+17868187337
Emailchristian.costantini@redax.it
Phone+17868187337
Emailchristian.costantini@redax.it
Phone+17868187337
Emailchristian.costantini@redax.it
Phone+17868187337
Emailchristian.costantini@redax.it
Phone+17868187337
Emailchristian.costantini@redax.it
Phone+17868187337
Emailchristian.costantini@redax.it
Phone+17868187337
Emailchristian.costantini@redax.it
Phone+17868187337
Emailchristian.costantini@redax.it
Phone+17868187337
Emailchristian.costantini@redax.it
Phone+17868187337
Emailchristian.costantini@redax.it
Phone+17868187337
Emailchristian.costantini@redax.it
Phone+17868187337
Emailchristian.costantini@redax.it
Phone+17868187337
Emailchristian.costantini@redax.it
Phone+17868187337
Emailchristian.costantini@redax.it
Phone+17868187337
Emailchristian.costantini@redax.it

Operating and Storage Conditions

Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108034139294636 [Primary]
GS118034139294633 [Package]
Contains: 08034139294636
Package: Box [20 Units]
In Commercial Distribution

FDA Product Code

GBXCatheter, Irrigation

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-13
Device Publish Date2021-05-05

Devices Manufactured by REDAX SPA

08034139290959 - Universal connector 1/4 x 1/4 Fr 24-362021-05-19 Fittinig device designed to facilitate the connection of the tubes/drainage catheters.
18034139290970 - Connector for drainage Fr 32-402021-05-19 Fittinig device designed to facilitate the connection of the tubes/drainage catheters.
08034139290980 - Y connector 3/8 Fr 36-402021-05-19 Fittinig device designed to facilitate the connection of the tubes/drainage catheters.
18034139291014 - Y connector 3/8 1/4 1/4 Fr 24-322021-05-19 Fittinig device designed to facilitate the connection of the tubes/drainage catheters.
18034139291021 - Y connector 1/4 1/4 1/4 Fr 24-322021-05-19 Fittinig device designed to facilitate the connection of the tubes/drainage catheters.
18034139291045 - Y connector 3/8 Fr 15-202021-05-19 Fittinig device designed to facilitate the connection of the tubes/drainage catheters.
18034139291120 - Connector for Spiral Drain Fr 15-192021-05-19 Fittinig device designed to facilitate the connection of the tubes/drainage catheters.
18034139295494 - Y connector 1/4 Fr 18-242021-05-19 Fittinig device designed to facilitate the connection of the tubes/drainage catheters.

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